Cinfamucol acetylcysteine 200 mg powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfamucol acetylcysteine 200 mg powder for oral solution

acetylcysteine

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Contents of the leaflet

1. What cinfamucol acetylcysteine is and what it is used for
2. What you need to know before taking cinfamucol acetylcysteine
3. How to take cinfamucol acetylcysteine
4. Possible adverse effects
5. How to store cinfamucol acetylcysteine
6. Contents of the pack and other information

1. What is cinfamucol acetylcysteine and what is it used for

Acetylcysteine, the active ingredient in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it thinner and easier to expel.

This medicine is indicated for reducing the viscosity of mucus and phlegm, facilitating their expulsion, in catarrhal and influenza-like conditions in adults and adolescents aged 12 years and older. You should consult a doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before starting to take cinfamucol acetylcysteine

Do not take cinfamucol acetylcysteine

• If you are allergic to acetylcysteine and its derivatives, or to any of the other ingredients of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfamucol acetylcysteine.

If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.

The possible sulphurous odor (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor. Caution is advised in patients with peptic ulcer or a history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease as treatment progresses.

Children and adolescents

Children between 2 and 12 years of age should not take this medicine. There are other formulations more suitable for this population.

Other medicines and acetylcysteine

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Concomitant therapy with nitroglycerin may cause headache, and hypotension should be monitored, as it may be severe.

Concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medicines (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may lead to accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines containing antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), the administration of cinfamucol acetylcysteine should be separated by at least 2 hours.

It is not recommended to dissolve cinfamucol acetylcysteine together with other medicines.

Taking cinfamucol acetylcysteine with food and drinks

Taking this medicine with food and drinks does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid using this medicine during pregnancy.

Its use should be avoided during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive or use machines.

cinfamucol acetylcysteine contains aspartame

This medicine contains 6.67 mg of aspartame per sachet.

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

cinfamucol acetylcysteine contains orange-yellow S

This medicine may cause allergic reactions because it contains orange-yellow S (E-110). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take cinfamucol acetylcysteine

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents between 12 and 18 years of age

Take 1 sachet (200 mg of acetylcysteine) per dose, 3 times a day. Do not exceed a daily dose of 3 sachets (600 mg).

Use in children

Children under 12 years of age should not take this medicine. Other formulations more suitable for this population are available.

How to take it

cinfamucol acetylcysteine is taken orally.

Dissolve the contents of the sachet in a glass of water. It is recommended to drink plenty of fluids throughout the day.

Consult a doctor if your condition worsens or does not improve after 5 days of treatment.

If you take more cinfamucol acetylcysteine than you should

If you take more cinfamucol acetylcysteine than recommended, you may experience nausea, vomiting, burning sensation, stomach pain, diarrhea, or any other adverse effect listed in section 4. Possible side effects.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another medicine.

Frequency not known (cannot be estimated from available data): facial swelling.

If any changes occur in the skin or mucous membranes, administration of acetylcysteine must be stopped immediately and medical advice sought.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of cinfamucol acetylcysteine

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfamucol acetylcysteine

• The active substance is acetylcysteine. Each sachet contains 200 mg of acetylcysteine.
• The other components are: aspartame (E-951), orange flavour (flavouring preparations, flavouring substances, natural flavouring substances, corn maltodextrin, gum arabic (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)), orange-yellow colouring S (E-110), mannitol (E-421) and anhydrous colloidal silica.

Appearance of the product and contents of the pack

cinfamucol acetylcysteine is presented in the form of sachets containing a homogeneous powder with an orange colour and flavour.

Each pack contains 20 sachets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: December 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/